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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Mar 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
EC Number:
610-201-0
Cas Number:
446292-08-6
Molecular formula:
C22 H19 N3 O6
IUPAC Name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
Details on test material:
Oxaphthalimid, white powder, batch number BXR34BR, content 99.8%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
There were no systemic intolerance reactions.

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1  Corneal Opacity  0 0.0
   Iritis  0  0  0  0.0
   Redness conjunctivae  1  0  0  0.3
   Chemosis conjunctivae  0  0  0  0.0
 2   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  1  0  0  0.3
    Chemosis conjunctivae  0  0  0  0.0
 3   Corneal Opacity  0  0  0  0.0
    Iritis  0  0  0  0.0
    Redness conjunctivae  0  0  0  0.0
    Chemosis conjunctivae  0  0  0  0.0

All animals showed reddening of the conjunctivae 1 h after administration.

Applicant's summary and conclusion

Executive summary:

0.1 g of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 females and after 24 h the treated eyes were rinsed with physiologic saline.

Evaluation of eye irritation was made according to Draize.

According to the classification criteria Oxaphthalimid is not irritating to eyes.